Cleveland State University
EngagedScholarship@CSU
Journal of Law and Health
Law Journals
2015
Legislating Morality Progressively - The
Contraceptive Coverage Mandate, Religious
Freedom, and Public Health Policy and Ethics
Michael J. DeBoer
Faulkner University, Thomas Goode Jones School of Law
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Recommended Citation
Michael J. DeBoer,Legislating Morality Progressively - The Contraceptive Coverage Mandate, Religious Freedom, and Public Health Policy and Ethics, 28 J.L. & Health 62 (2015)
62
LEGISLATING MORALITY PROGRESSIVELY—
THE CONTRACEPTIVE COVERAGE MANDATE,
RELIGIOUS FREEDOM, AND PUBLIC HEALTH
POLICY AND ETHICS
MICHAEL J.DEBOER*
I.
I
NTRODUCTION... 63
II.
S
TATUTORY ANDR
EGULATORYB
ACKGROUNDR
EGARDING THEC
ONTRACEPTIVEC
OVERAGEM
ANDATE... 67
A. The Relevant Affordable Care Act Provisions ...
67
B. The Regulations ...
68
1. The July 2010 Interim Final Rulemaking ... 68
2. The Institute of Medicine Committee
Recommendations ... 70
3. The HRSA August 2011 Comprehensive
Guidelines ... 72
4. The August 2011 Amended Interim Final
Rulemaking ... 72
5. The February 2012 Final Rulemaking ... 74
6. The February and August 2012 Guidance ... 77
7. The March 2012 Advance Notice of Proposed
Rulemaking (ANPRM) ... 77
8. The February 2013 Proposed Rulemaking ... 79
9. The July 2013 Final Rulemaking ... 80
10. The June 2013 Guidance Documents ... 82
C. Some Observations Regarding the Processes Used
to Develop the Mandate ...
82
III.
A
NALYSISU
NDER THER
ELIGIOUSF
REEDOMR
ESTORATIONA
CT... 84
A. The Departments’ Rulemakings ...
86
B. The RFRA Standard ...
88
C. The Supreme Court’s Ruling ...
90
D. Other Challenges ...
92
* Associate Professor of Law, Faulkner University, Thomas Goode Jones School of Law. The author thanks the editors of the Journal of Law & Health for their invitation to present this
IV.
A
NALYSISU
NDER AP
UBLICH
EALTHP
OLICY ANDE
THICSF
RAMEWORK... 94
A. The ACA, the Mandate, Public Health, and Social
Justice ...
94
B. A Brief Overview of the Analytical Framework ...
97
1.
The General Moral Considerations ... 98
a.
The Nine General Moral Considerations ...
98
b.
The Balancing of General Moral
Considerations of Indeterminate Weight
or Strength ...
99
2.
The Justificatory Conditions ... 100
C. An Application of the Analytical Framework...
100
1.
The First Three General Moral Considerations .... 101
2.
The Other General Moral Considerations ... 104
a. Justice ...
104
b. Autonomy/Liberty...
106
c.
Integrity ...
107
d.
Transparency ...
108
e. Trust ...
109
3.
The Justificatory Conditions ... 110
a.
Effectiveness ...
110
b.
Proportionality ...
111
c.
Necessity and Least Infringement ...
112
d.
Public Justification ...
115
D. The Administration’s Failure of Deliberation and
Justification in This Public Health Initiative ...
116
V.
C
ONCLUSION... 116
I. INTRODUCTION
In the area of reproductive rights in the United States, one of the biggest developments in the last several years has been the so-called contraceptive coverage mandate. The mandate requires employers, group health plans, and health insurance issuers to cover all United States Food and Drug Administration (FDA)-approved contraceptive methods, sterilization procedures, and patient education and counseling.1 The Obama Administration chose to mandate this coverage in rules it
promulgated, specifying the preventive health services for women that must be covered under the Affordable Care Act (ACA).2
1 See infra Part II.
Since its promulgation, hundreds of citizens, businesses, and nonprofit and religious organizations have challenged the mandate in dozens of lawsuits, which are at various stages of litigation.3 The Supreme Court of the United States ruled on two
cases that were brought by family-owned businesses that objected to four of the twenty FDA-approved contraceptives.4 Both Hobby Lobby Stores, Inc. (Hobby
Lobby) and Conestoga Wood Specialties Corporation (Conestoga Wood) objected to two drugs, commonly known as “Plan B” and “Ella,” as well as to two intrauterine devices (IUDs) that operate after fertilization and prevent uterine implantation of fertilized eggs (human embryos), thus causing an abortifacient effect.5 Although
Hobby Lobby and Conestoga Wood objected to paying for these four methods of contraception, they otherwise provided health insurance to their employees, including methods of contraception that they do not oppose on religious grounds.6
This Article studies the contraceptive coverage mandate from three different perspectives. First, it provides a historical treatment of the regulatory rules adopted by agencies in the Obama Administration – specifically, the Departments of the Treasury, Labor, and Health and Human Services, which this Article collectively refers to as “the Administration” or “the Departments” – that imposed the mandate, focusing specifically on the rulemaking processes used to develop and promulgate the rules. In performing this historical study, the Article traces the development of the mandate from its root in the ACA to full implementation in legislative (substantive) rules finalized by the Administration in the summer of 2013.7 Second,
111-152, 124 Stat. 1029 (2010). This Article will refer to these laws collectively as either the “Affordable Care Act” or the “ACA.” For a discussion of the relevant provisions of the ACA, the mandate, and the regulatory rules developed by the Administration that implement the mandate, see infra Part II.
3 See THE BECKET FUND FOR RELIGIOUS LIBERTY, http://www.becketfund.org/hhs informationcentral (last visited Nov. 8, 2014) (accessible and comprehensive collection of cases and litigation documents); seealso NATIONAL WOMEN’S LAW CENTER, http://www.
nwlc.org/status-lawsuits-challenging-affordable-care-acts-birth-control-coverage-benefit (last visited Nov. 8, 2014) (survey of lawsuits and summaries of the status of pending cases).
4 Burwell v. Hobby Lobby Stores, Inc., 134 S. Ct. 2751 (2014). In Hobby Lobby Stores, the Court affirmed the Tenth Circuit’s ruling in Hobby Lobby Stores, Inc. v. Sebelius, 723 F.3d 1114 (10th Cir. 2013), and reversed and remanded the ruling of the Third Circuit in Conestoga Wood Specialties Corp. v. Burwell, 724 F.3d 377 (3d Cir. 2013). See also Burwell v. Hobby Lobby Stores, Inc., SCOTUSBLOG,
http://www.scotusblog.com/case-files/cases/sebelius-v-hobby-lobby-stores-inc (last visited Nov. 8, 2014) (materials and commentary relating to the Hobby Lobby Stores case); see also Conestoga Wood Specialties Corp. v. Burwell, SCOTUSBLOG,
http://www.scotusblog.com/case-files/cases/conestoga-wood-specialties-corp-v-sebelius (last visited Nov. 8, 2014) (materials and commentary relating to the Conestoga Wood Specialties case).
5 Brief for Respondents at *4, sub nom Sebelius v. Hobby Lobby Stores, Inc., 2014 WL 546899 (No. 13-354); Brief for Petitioners at *4, sub nom Conestoga Wood Specialties Corp.
v. Sebelius, 2014 WL 173487 (No. 13-356).
6 See Brief for Petitioners at *5, Conestoga Wood Specialties Corp. v. Sebelius, 2014 WL 173487 (No. 13-356); Petition for Writ of Certiorari at *1, Conestoga Wood Specialties Corp. v. Sebelius, 2013 WL 5291412 (No. 13-356); see also Hobby Lobby Media Information and Fact Sheet,THE BECKET FUND FOR RELIGIOUS LIBERTY, http://www.becketfund.org/hobby lobbyfactsheet (last visited Nov. 8, 2014).
this Article evaluates the mandate under the legal framework established by Congress in the Religious Freedom Restoration Act (RFRA),8 focusing especially on
the Administration’s RFRA analysis in its rulemaking materials and the Supreme Court’s recent ruling regarding the mandate.9 Third, it analyzes the mandate under a
moral and policy-based framework proposed by a team of leading bioethicists, public health policy analysts, and scholars. It applies the team’s proposed framework to determine whether the Departments that developed and adopted the mandate satisfied the various moral and policy considerations that these experts have highlighted.10
The analyses in this Article will establish the following four points:
(1) The Administration chose to employ regulatory procedures that failed to ensure transparency, hindered meaningful public participation, hampered dialogue between policymakers and interested individuals and organizations, and deprived the public of the deliberative process agency rulemaking is supposed to afford.
(2) In its rulemaking, the Administration’s consideration of the First Amendment and RFRA was cursory and untimely. Consequently, the Administration failed adequately to consider the religious freedom implications of creating by regulatory rule a positive right to coverage that conflicted with a negative right grounded in the First Amendment that Congress had reinforced in RFRA.
(3) In developing the mandate, the Administration failed adequately to address basic moral and policy considerations that provide concrete guidance for evaluating and justifying public health initiatives. Consequently, the Administration’s deliberations about and justifications for this public health initiative were unsatisfactory, failing adequately to resolve conflicts that the initiative created among general moral considerations.
(4) In adopting the regulatory rules and imposing the mandate, the Administration “legislated” its conception of morality. The mandate does not simply represent the policy judgments of the policymakers, but also the moral judgments of the policymakers based upon their progressive moral vision and values.11 Thus, although the mandate is framed in regulatory,
8 Religious Freedom Restoration Act of 1993, Pub. L. No. 13-141, 107 Stat. 1488 (1993).
9 See infra Part III.
10 See infra Part IV.
11 The aim of this Article is not to explicate progressive morality, nor to explore its ideological foundations, nor to trace its contours. Rather, it is to analyze the mandate from three perspectives. In the process, however, this Article will reveal that moral decision-making undergirds the mandate. The term “progressive” here refers to a set of ideological, moral, and political beliefs and values shared by proponents of a current movement as well as proponents of an earlier movement in United States history. The earlier movement, which historians identify with the Progressive Era of the late 19th and early 20th centuries, altered the
American landscape in fundamental ways, and its effects were felt in all sectors of society and culture—business, education, government, law, religion, and science. See generally LEWIS L. GOULD,AMERICA IN THE PROGRESSIVE ERA,1890–1914 (2001); THE PROGRESSIVE ERA (Lewis
L. Gould, ed., 1974); WALTER NUGENT,PROGRESSIVISM:AVERY SHORT INTRODUCTION
(2010); Daniel T. Rogers, In Search of Progressivism, 10 REV.AM.HIST. 113 (1982). In
public health, social scientific, and medical terminology, it advances a particular moral vision, is premised upon the moral values held by the policymakers, and reflects their conception of what is “good” and what constitutes a “good society.”12
and government, its administrative apparatus, and “administratively organized ‘communities’ of highly trained, objective professionals” would lead society forward and bring about transformative social, legal, and economic reforms. Joel D. Schwartz, Book Review, Liberty, Democracy, and the Origins of American Bureaucracy,97 HARV.L.REV. 815, 820 (1984).
For the Progressives, science, expertise, and administration held the promise of the future, and the interests of businesses and business owners and the concerns of lay people were
understood as obstacles to the desired progress. See generally RICHARD L.MCCORMICK,THE
PARTY PERIOD AND PUBLIC POLICY:AMERICAN POLITICS FROM THE AGE OF JACKSON TO THE
PROGRESSIVE ERA (1988); WILLIAM E.NELSON,THE ROOTS OF AMERICAN BUREAUCRACY
1830-1900 (1982); MARTIN SHAPIRO,WHO GUARDS THE GUARDIANS?:JUDICIAL CONTROL OF
ADMINISTRATION (1988); DWIGHT WALDO,THE ADMINISTRATIVE STATE:ASTUDY OF THE
POLITICAL THEORY OF AMERICAN PUBLIC ADMINISTRATION (1984); ROBERT H.WIEBE,THE
SEARCH FOR ORDER 1877-1920 (1967); Gerald E. Frug, The Ideology of Bureaucracy in American Law, 97 HARV.L.REV. 1276 (1984); Robert L. Rabin, Federal Regulation in Historical Perspective, 38 STAN.L.REV.1189 (1986). As for the current manifestation of
progressivism, scholars on both the left and the right have begun to identify a progressive movement currently underway. See Charles Murray, The Trouble Isn’t Liberals. It’s
Progressives. WALL STREET J. (July 1, 2014) (“[P]rogressive intellectuals [a century ago] were passionate advocates of rule by disinterested experts led by a strong unifying leader. They were in favor of using the state to mold social institutions in the interests of the collective. They thought that individualism and the Constitution were both outmoded. . . . It is that core philosophy extolling the urge to mold society that still animates progressives today—a mindset that produces the shutdown of debate and growing intolerance that we are witnessing in today’s America. Such thinking on the left also is behind the rationales for indulging President Obama in his anti-constitutional use of executive power. . . . [W]e should start using ‘liberal’ to designate the good guys on the left, reserving ‘progressive’ for those who are enthusiastic about an unrestrained regulatory state, who think it’s just fine to subordinate the interests of individuals to large social projects, who cheer the president’s abuse of executive power and who have no problem rationalizing the stifling of dissent.”); Jeffrey D. Sachs, The New Progressive Movement, N.Y.TIMES (Nov. 12, 2011) (“Following our recent financial calamity, a third progressive era is likely to be in the making. This one should aim for three things. The first is a revival of crucial public services, especially education, training, public investment and environmental protection. The second is the end of a climate of impunity that encouraged nearly every Wall Street firm to commit financial fraud. The third is to re-establish the supremacy of people votes over dollar votes in Washington. . . . The new movement also needs to build a public policy platform. The American people have it absolutely right on the three main points of a new agenda. To put it simply: tax the rich, end the wars and restore honest and effective government for all.”)
II. STATUTORY AND REGULATORY BACKGROUND REGARDING THE CONTRACEPTIVE
COVERAGE MANDATE
A. The Relevant Affordable Care Act Provisions
The ACA did not mandate that employers and health insurance plans cover contraceptives, sterilization, or patient education and services. Rather, the ACA required group health plans and health insurance issuers offering group or individual health insurance coverage to cover several broad categories of preventive health services.13 The following were among the required preventive health services:
(1) Evidence-based items or services recommended with a rating of A or B by the United States Preventive Services Task Force (USPSTF);14 and
(2) As to women, preventive care and screenings (in addition to those items and services recommended by the USPSTF) provided for in comprehensive guidelines supported by the U.S. Health Resources and Services Administration (HRSA).15
13 Patient Protection and Affordable Care Act, Pub. L. No. 111-148, § 1001, 124 Stat. 131 (codified at 42 U.S.C. § 300gg-13 (2012)).
14 Id. SeeAbout the USPSTF,U.S.PREVENTIVE SERVICES TASK FORCE,
http://www.uspreventiveservicestaskforce.org/Page/Name/about-the-uspstf (last visited Nov. 9, 2014). The USPSTF is an independent, volunteer panel of primary care providers with expertise in prevention and evidence-based medicine. Id. The task force conducts scientific
evidence reviews of clinical preventive services (such as screenings, counseling, and preventive medications) and makes recommendations for primary care clinicians and health systems. Janelle Guirguis-Blake, et al., Current Processes of the U.S. Preventive Service Task Force: Refining Evidence-Based Recommendation Development, 147 ANNALS OF INTERNAL
MEDICINE 117, 117 (2007), available at http://www.uspreventiveservicestaskforce.org/
Home/GetFile/6/7/currprocess/pdf. The Agency for Healthcare Research and Quality (AHRQ) within the Department of Health and Human Services (HHS) provides the task force
administrative, research, technical, and dissemination support. See id. The Director of AHRQ
appoints new USPSTF members, with guidance provided by the Chair of the task force. U.S. Preventive Services Task Force (USPSTF): An Introduction, AGENCY FOR HEALTHCARE
RESEARCH AND QUALITY,
http://www.ahrq.gov/professionals/clinicians-providers/guidelines-recommendations/uspstf/index.html (last visited Nov. 9, 2014).
15 Patient Protection and Affordable Care Act, Pub. L. No. 111-148, § 1001, 124 Stat. 131 (codified at 42 U.S.C. § 300gg-13 (2012)). HRSA is an agency within HHS that seeks to improve access to health care services. See About HRSA,HEALTH RES.&SERVS.ADMIN.,
The ACA prohibited the imposition of cost-sharing requirements (e.g, copayments, coinsurance, and deductibles) as to these covered items and services.16
As the grandfathered status of health plans is lost over time, most health plans and health insurance issuers (and employers) will be required to cover the specified preventive services free of charge to beneficiaries and employees.17
B. The Regulations
Subsequently, the Obama Administration adopted regulatory rules implementing these provisions of the ACA. It was in these rulemakings that the Administration decided to include all FDA-approved contraceptive methods, sterilization procedures, and patient education and counseling within the required package of covered preventive health services.
1. The July 2010 Interim Final Rulemaking
In July 2010, about four months after the ACA was enacted,18 the Administration
issued a set of interim final rules.19 These interim final rules, consistent with the
ACA, required health plans and health insurance issuers to provide coverage of the following relevant categories of items and services:
(1) Evidence-based items and services recommended by the USPSTF with a rating of A or B; and
(2) For women, evidence-informed preventive care and screening provided for in comprehensive guidelines supported by the HRSA.20
16 See Patient Protection and Affordable Care Act, Pub. L. No. 111-148, § 1001, 124 Stat. 131 (2010) (codified at 42 U.S.C. § 300gg-13 (2012)). The ACA elsewhere specifies that the term “cost-sharing” includes: “deductibles, coinsurance, copayments, or similar charges,” and “any other expenditure required of an insured individual which is a qualified medical expense . . . with respect to essential health benefits covered by the plan.” Id. at § 1302(c)(3)(A)
(codified at 42 U.S.C. § 18022(c)(3)(A)).
17 See Patient Protection and Affordable Care Act, Pub. L. No. 111-148, § 1251, 124 Stat. 119 (2010) (codified at 42 U.S.C. § 18011). The Departments’ regulatory materials indicate that the grandfathered status under the ACA “is only transitional in effect, and [that] it is expected that a majority of plans will lose their grandfathered status by the end of 2013.” See also Coverage of Certain Preventive Services Under the Affordable Care Act, 78 Fed. Reg.
39,870, 39,887 n.49 (July 2, 2013) [hereinafter July 2013 Final Rules].
18 President Obama signed the ACA on March 23 and the HCERA on March 30 of 2010.
See supra note2.
19 See Interim Final Rules for Group Health Plans and Health Insurance Issuers Relating to Coverage of Preventive Services Under the Patient Protection and Affordable Care Act, 75 Fed. Reg. 41,726, 41,728 (July 19, 2010) [hereinafter Interim Final Rules]. In the regulatory materials, the Departments indicated that they were issuing other interim final rules to implement various provisions of the ACA, including: the provision requiring dependent coverage of children to age 26; the provision relating to status as a grandfathered health plan; and the provisions prohibiting preexisting condition exclusions, regarding lifetime and annual dollar limits on benefits, regarding restrictions on rescissions, and regarding patient
protections. Id.
The regulatory materials indicated that the Department of Health and Human Services (HHS) was developing comprehensive guidelines for preventive care and screening for women and expected to issue them no later than August 1, 2011.21
These interim final rules were effective on September 17, 2010, the same date comments from the public and interested persons were due.22 The Departments’
decision to issue interim final rules, instead of following the standard notice-and-comment process that would have ensured meaningful public participation and full vetting of the rules before they went into effect,23 meant that the rules would be
effective without comments from the public on any proposed rules being reviewed and considered by the Departments prior to the effective date.24 The Administration
justified its decision to sidestep standard rulemaking procedures and instead to use the truncated rulemaking process on the following two grounds:
(1) Statutory grounds in the Internal Revenue Code, the Employee Retirement Income Security Act, and the Public Health Service Act;25 and
(2) Good cause because “a full public notice and comment process” was impracticable and contrary to the public interest.26
The Departments’ position was thus that they had statutory authority to employ the interim final rulemaking process and that the good cause exception to notice-and-comment rulemaking applied. Citing provisions of the ACA, the Departments asserted that this expedited rulemaking process was necessary to ensure that the regulations would be in place for plan years and policy years beginning on or after September 23, 2010, and that coverage would be implemented on a timely basis.27
Accordingly, the Departments determined to push the rules through, even though it meant that public participation would be restricted and that their consideration of the feedback received from the public regarding the rules would be delayed by nearly a year.
21 Id. at 41,728.
22 Id. at 41,726.
23 Under the Administrative Procedure Act (APA), agencies ordinarily adopt regulations pursuant to standard rulemaking procedures that require agencies (1) to give the public and interested persons notice of proposed rules, (2) to afford the public opportunity to comment on (i.e., participate in the rulemaking and give feedback regarding) proposals, and (3) to review the feedback received, modify proposals based upon the feedback, state in writing the reasons for adopting the final version of the rules, and issue the final rules. Upon issuing final rules, agencies specify the effective date. See 5 U.S.C. § 553. The APA provides some exceptions to
these procedural requirements, including the good cause exemption when notice and the public procedure are impracticable, unnecessary, or contrary to the public interest. 5 U.S.C. § 553(a), (b)(A), & (b)(B).
24 See Michael Asimow, Interim-Final Rules: Making Haste Slowly, 51 ADMIN.L.REV. 703, 704 (1999) (“Interim-final rules are rules adopted by federal agencies that become effective without prior notice and public comment and that invite post-effective public comment . . . . [The interim-final] rule is effective immediately but it also serves as a notice of proposed rulemaking for the final rule that will supplant it.”).
25 SeeInterim Final Rules, supra note 19, at 41,729–30 (listing as relevant federal statutes 26 U.S.C. § 9833 (2012), 29 U.S.C. § 1191c (2012), 42 U.S.C. § 300gg-92 (2012)).
It quickly became apparent that aspects of the HRSA guidelines being developed by HHS would be controversial. Upon the Departments’ issuance of the interim final rules and public announcement regarding the development of the guidelines, the Planned Parenthood Federation of America launched its campaign to ensure that the guidelines would require coverage of family planning and all FDA-approved contraceptives with no cost-sharing.28 Two months later, the United States
Conference of Catholic Bishops (USCCB) urged the Administration not to include coverage of contraception and sterilization in the list of preventive services that group and individual health plans must cover.29
2. The Institute of Medicine Committee Recommendations
Although the interim final rules did not mandate coverage of contraceptive and sterilization services, the rulemaking paved the way by requiring health plans and health insurance issuers to cover evidence-informed preventive care and screenings provided for in comprehensive guidelines supported by HRSA. The Departments indicated that the guidelines were in development and expected by August 1, 2011.30
The HHS Office of the Assistant Secretary for Planning and Evaluation provided funds for the Institute of Medicine (IOM) to convene a committee to conduct a
28 See Press Release, Planned Parenthood Fed’n of America, Planned Parenthood Supports Initial White House Regulations on Preventive Care; Highlights Need for New Guidelines on Women’s Preventive Health to Include Family Planning (July 14, 2010), http://www.planned parenthood.org/about-us/newsroom/press-releases/planned-parenthood-supports-initial-white-house-regulations-preventive-care-highlights-need-new. When the interim final rules were issued, Planned Parenthood was ready to go with its campaign, and it was fortunate to have individuals friendly to its viewpoint well-positioned within HHS. Reports have shown that Kathleen Sebelius, the HHS Secretary who approved the mandate, had longstanding ties to and received political contributions from the late George Tiller, a Kansas doctor well-known for performing late-term abortions. See Deanna Candler, The Advisors Behind the
Contraceptive Mandate, LIVE ACTION BLOG (Feb. 24, 2012), http://liveaction.org/blog/the-advisors-behind-the-contraception-mandate/; Penny Starr, Sebelius: ‘Keeping Our Children Safe . . . Most Fundamental Task,’ CNSNEWS.COM (May 7, 2013), http://cnsnews.com/news/ article/sebelius-keeping-our-children-safe-most-fundamental-task. Additionally, Washington, D.C. attorney and former drug lobbyist William B. Schultz, whose clients at Zuckerman Spaeder LLP included Barr Laboratories, the maker of Plan B, became HHS’s principal deputy general counsel and acting general counsel in 2011 and HHS’s general counsel in 2013. See Timothy P. Carney, Obama Nominates Ex-drug Lobbyist as Top HHS Lawyer,
WASHINGTON EXAMINER (Dec. 19, 2012),
http://www.washingtonexaminer.com/tim-carney-obama-nominates-ex-drug-lobbyist-as-top-hhs-lawyer/article/2516459; Steven Ertelt, Obama Names Lobbyist for Plan B Drug as Top HHS Lawyer, FREE REPUBLIC (Dec. 20, 2012),
http://www.freerepublic.com/focus/f-news/2971046/posts; U.S. Department of Health & Human Services, Press Release, HHS Secretary Sebelius Announces Senate Confirmation of William B. Schultz, Nominee for General Counsel, Department of Health and Human Services
(Apr. 26, 2013), http://www.hhs.gov/news/press/2013pres/04/20130426a.html.
29 Press Release, U.S. Conference of Catholic Bishops, USCCB Officials Urge HHS Not to
Require Coverage of Contraception and Sterilization (Sept. 20, 2010),
review of what preventive services are necessary for women’s health and well-being and what services should be considered in developing comprehensive guidelines.31
The IOM Committee on Preventive Services for Women was formed to develop recommendations to fill possible gaps in recommended preventive services.32 The
sixteen-member committee held five meetings over a six-month period and conducted three open sessions for presentations by invited stakeholders, women’s health experts, and reproductive rights advocates and to hear from members of the public.33 Pro-choice and reproductive-choice advocates and interest groups such
Planned Parenthood, the Guttmacher Institute, and the National Women’s Law Center were well-represented among the committee members and the invited presenters.34
On July 19, 2011, the Committee issued a 235-page report that included various recommendations.35 The Committee recommended that eight preventive health
services for women be added to the services that health plans must cover at no cost to patients.36 Among them was a recommendation that the full range of
“FDA-approved contraceptive methods, sterilization procedures, and patient education and counseling (i.e., family planning services) for women” with reproductive capacity be covered.37 For this recommendation, the Committee’s express objectives were
“preventing unintended pregnancy and promoting healthy birth spacing.”38
One member, Anthony Lo Sasso, Ph.D., dissented from the committee report, expressing concern that the compressed period of time prevented the Committee from conducting a serious, systematic review of all evidence for preventive services.39 Beyond the time constraints, he noted that the Committee’s process
“lacked transparency and was largely subject to the preferences of the Committee’s
31 See COMMITTEE ON PREVENTIVE SERVICES FOR WOMEN,INSTITUTE OF MEDICINE, CLINICAL PREVENTIVE SERVICES FOR WOMEN:CLOSING THE GAPS 1–2 (2011) [hereinafter CLOSING THE GAPS REPORT].
32 Id. at 2.
33 Id. at v–vi, 217–21, 223–30.
34 See id. at 223–30 (referencing Appendix C and biographies provided by the Committee regarding members Dr. Angela Diaz, Dr. Francisco Garcia, Dr. Paula A. Johnson, and Dr. Alina Salganicoff, which fail to note the prior advocacy and interest group affiliations and memberships of these individuals); see id. at 218-19 (identifying several invited presenters); see also Helen M. Alvaré, No Compelling Interest: The “Birth Control” Mandate and Religious Freedom, 58 VILL.L.REV. 379, 430 (2013) (citing Letter from Anna Franzonello,
Staff Counsel, Ams. United for Life, to Ctrs. for Medicare and Medicaid Servs. (Sept. 29, 2011) (on file at www.freedom2care.org/docLib/20110929_AmericansUnitedforLife preventiveservicescomment.pdf.).
35 See CLOSING THE GAPS REPORT, supra note 31, at ix–x; see also Press Release,Institute of Medicine of the National Academies of Science, Report at a Glance (July 19, 2011),
http://www.iom.edu/Reports/2011/Clinical-Preventive-Services-for-Women-Closing-the-Gaps/Press-Release.aspx.
36 See CLOSING THE GAPS REPORT, supra note 31, at 1, 7–12.
37 Id. at 10, 109–10.
composition,” in which “a mix of objective and subjective determinations [were] filtered through a lens of advocacy.”40
3. The HRSA August 2011 Comprehensive Guidelines
Soon thereafter, HRSA adopted the IOM Committee’s recommendations and issued the Women’s Preventive Services Guidelines.41 Under the HRSA-supported
coverage guidelines, non-grandfathered plans are generally required to cover various preventive services without cost sharing, including the following: “All Food and Drug Administration approved contraceptive methods, sterilization procedures, and patient education and counseling for all women with reproductive capacity.”42
4. The August 2011 Amended Interim Final Rulemaking
The Departments then issued amended interim final rules.43 These rules reiterated
the requirement that health plan coverage must include preventive care and screenings provided for in binding comprehensive guidelines supported by HRSA.44
In this rulemaking, and for the first time, the Administration addressed the considerable volume of comments submitted by the public and interested persons regarding the first set of interim final rules.45 Some of the commenters raised
concerns regarding the requirement that religious employers cover contraceptive services that might be objectionable on religious grounds.46
In these rules, the Departments acknowledged the appropriateness of HRSA considering the effect of a coverage mandate on the religious beliefs of certain employers when employees in “certain religious positions participate,” and they expressed a willingness to “provide for a religious accommodation that respects the unique relationship between a house of worship and its employees in ministerial positions.”47 Accordingly, the Departments granted HRSA discretion to establish an
exemption for certain religious employers as to contraceptive coverage.48 The
40 Id. at 232.
41 Health Res. and Serv. Admin., U.S. Dep’t of Health and Human Servs., Affordable Care
Act Expands Prevention Coverage for Women’s Health and Well-Being, HRSA.GOV, http://www.hrsa.gov/womensguidelines (last visited Nov. 9, 2014).
42 Id.See also Press Release, Dep’t of Health and Human Servs., Affordable Care Act
Ensures Women Receive Preventive Services at No Additional Cost (Aug. 1, 2011) (on file at
http://www.hhs.gov/news/press/2011pres/08/20110801b.html).
43 Group Health Plans and Health Insurance Issuers Relating to Coverage of Preventive Services Under the Patient Protection and Affordable Care Act, 76 Fed. Reg. 46,621 (Aug. 3, 2011) (to be codified at 26 C.F.R. pt. 54, 29 C.F.R. pt. 2590, 45 C.F.R. pt. 147) [hereinafter
AmendedInterim Final Rules].
44 Id. at 46,625–26.
45 See id. at 46,623 (stating that the public had provided “considerable feedback regarding which preventive services for women” should be covered).
46 See id.
47 Id.
Departments defined the term “religious employer” narrowly for purposes of the mandate, requiring an employer to meet the following to qualify for the exemption:
(1) The inculcation of religious values must be the purpose of the organization;
(2) The organization must primarily employ persons who share the religious tenets of the organization;
(3) The organization must primarily serve persons who share the religious tenets of the organization; and
(4) The organization must be a nonprofit organization as described in section 6033(a)(1) and section 6033(a)(3)(A)(i) or (iii) of the Internal Revenue Code of 1986, as amended.49
The Departments adopted this narrow definition in an effort to “reasonably balance” their goal of extending coverage to as many women as possible while respecting “the unique relationship between certain religious employers and their employees in certain religious positions.”50
The Administration again chose to employ the interim final rulemaking process, rather than the standard notice-and-comment rulemaking process.51 Unlike the
interim final rules issued one year earlier,52 the amended interim final rules were
effective immediately on August 1, 2011, and comments were due sixty days later on September 30, 2011.53 The Departments again justified their use of the truncated
rulemaking process by citing federal statutory authority.54 Additionally, in the
Departments’ view, the policy behind the generally required notice-and-comment process was satisfied by virtue of the public having had opportunity to comment on the initial interim final rules, and the amendments being made in the amended interim final rules were based on the public comments they received.55 Furthermore,
the Departments concluded, “an additional opportunity for public comment on the amended interim final rules before they were made effective was impracticable and contrary to the public interest.”56 Providing such an additional opportunity for public
comment would, in the Administration’s view, delay coverage for another year because many plan years and policy years begin in August or September.57 Similarly,
the Departments asserted that good cause existed for waiving the general requirement that final rules be made effective no sooner than thirty days after they
maintained by religious employers with respect to any requirement to cover” the mandated services); see also U.S. Dep’t of Health and Human Servs., supra note 41.
49 Amended Interim Final Rules, supra note 43, at 46,623.
50 Id.
51 Id. at 46,621.
52 Seesupra Part II.B.1.
53 Amended Interim Final Rules, supra note 43, at 46,621.
54 Id. at 46,624.
55 Id.
are published, and thus waived the thirty-day delay requirement, making the rules effective immediately.58
5. The February 2012 Final Rulemaking
In February 2012, the Departments finalized their interim final rules.59 In these
“final-final rules”60 regarding coverage of preventive services, the Departments
made no changes to their interim final rules,61 despite the fact that the Departments
received over 200,000 comments, and despite the lawsuits instituted challenging the mandate.62 The Administration’s decision to retain the narrow definition for the
exemption for religious employers occurred after a November 2011 meeting between President Obama and then-Archbishop Timothy Dolan, who was serving as president of the USCCB.63 At this meeting, President Obama indicated that he takes
the protection of the rights of conscience with the “utmost seriousness,” and that he did not want to impede the Catholic Church’s work.64 The final rules were effective
on April 16, 2012.65
The 200,000-plus responses were submitted by an array of individuals and organizations with different perspectives, and they raised a range of concerns, both in favor of and in opposition to the Administration’s narrow religious-employer exemption.66 Some commenters suggested that the religious-employer exemption
should be rescinded in its entirety so that benefits could extend to as many women as possible, and others, for the same reason, maintained that the exemption and the
58 Id.
59 See Group Health Plans and Health Insurance Issuers Relating to Coverage of
Preventive Services Under the Patient Protection and Affordable Care Act, 77 Fed. Reg. 8725 (Feb. 15, 2012) [hereinafter Final Rules].
60 See Asimow, supra note 24, at 705 (providing description of “final-final” and “interim-final” rule terminology).
61 Final Rules, supra note 59, at 8725.
62 Id. at 8,726. Belmont Abbey College in Belmont, North Carolina, and Colorado Christian University in Lakewood, Colorado, brought two early lawsuits challenging the mandate. Their lawsuits were filed in November 2011 and December 2011, respectively. The Becket Fund for Religious Liberty, Press Release, Belmont Abbey College Sues the Federal Government over New Obamacare Mandate (Nov. 10, 2011), http://www.becketfund.org/wp-content/uploads/2011/11/Press-Release-HHS-Final11.10.11.pdf; The Becket Fund for Religious Liberty, Press Release, Colorado Christian University First Evangelical University to Fight Abortifacient Mandate (Dec. 21, 2011), http://www.becketfund.org/?p=3304 &preview=true. For copies of the complaints filed in these cases, see Belmont Abbey College v. Sebelius, Case No. 1:11-cv-01989 (D.D.C. 2011),
http://www.becketfund.org/wp-content/uploads/2011/11/HHS-Complaint-Final11.10.11.pdf, and Colorado Christian University v. Sebelius, Case No. 11-cv-03350 (D. Colo. 2011), http://www.becketfund.org/ wp-content/uploads/2011/12/CCU-v-Sebelius-Complaint-final.pdf.
63 James Taranto, When the Archbishop Met the President, WALL ST.J., (Mar. 31, 2012), http://online.wsj.com/news/articles/SB10001424052702303816504577311800821270184.
64 Id. For additional discussion of this meeting, see infra Part IV.C.2.c.
65 Final Rules, supra note 59, at 8725.
definition of religious employer should not be broadened.67 The following arguments
were among those submitted in favor of expanding the exemption and broadening the definition of religious-employer: requiring organizations to pay for contraceptive services would compel them to act contrary to their religious beliefs; federal laws have provided for conscience clauses and religious exemptions broader than the currently contemplated exemption; and the narrow scope of the exemption raises concerns under the First Amendment and RFRA.68 Commenters also suggested
alternative definitions of religious employer.69
In addition to issuing this final-final rule adopting the narrowly defined exemption, the Administration announced that it would afford a one-year enforcement safe harbor to some non-exempt, nonprofit organizations with religious objections.70 The Departments indicated that, during the safe-harbor period, they
would develop and propose changes to the rules to meet two goals: (1) “providing contraceptive coverage without cost-sharing to individuals who want it,” and (2) “accommodating non-exempted, non-profit organizations’ religious objections to covering contraceptive services.”71 The Departments anticipated developing new
rules that would “require issuers to offer insurance without contraception coverage to such an employer (or plan sponsor) and simultaneously to offer contraceptive coverage directly to the employer’s plan participants (and their beneficiaries) who desire it, with no cost-sharing.”72
In justifying their decision to finalize the interim final rules without any change, the Departments listed various beneficial results expected from the mandated coverage including:
(1) Greater use of preventive services yields a healthier population and reduces health care costs;
(2) Women have unique health care needs (such as contraceptive services) and burdens;
(3) Women who are not immediately aware of a pregnancy and who experience unintended pregnancy may delay receiving prenatal care and continue to engage in high-risk behaviors and are at risk of preterm birth and low birth weight;
(4) For some women, pregnancy is contraindicated;
(5) Contraceptive use provides preventive health benefits relating to conditions other than pregnancy; and
67 Id. at 8726–27.
68 Id. at 8727; see also Religious Freedom Restoration Act, 42 U.S.C. § 2000bb et seq. (2012).
69 Final Rules, supra note 59, at 8725.
70 Id. at 8727–28; see Taranto supra note 63 (suggesting that this safe harbor, in Archbishop Dolan’s view, simply gave religious institutions one year to figure out how they would violate their consciences). Additionally, the political effect of the one-year safe harbor was to release some pressure and delay some fallout from the mandate until after the 2012 presidential election. See infra note 139.
(6) Employers will experience cost savings by avoiding medical costs related to pregnancy and indirect costs related to employee absences and reduced productivity.73
The Departments also identified several social concerns and goals behind their decision to mandate coverage of these services:
(1) The unique health needs of women place them at a disadvantage in the workforce compared to male coworkers;
(2) Access to contraception improves the social and economic status of women; (3) Contraceptive coverage eliminates disparities in the workforce by allowing
women to achieve equal status as healthy and productive members of the job force by reducing the number of unintended pregnancies and potentially unhealthy pregnancies;
(4) Cost sharing can be a significant barrier to effective contraception; and (5) Providing women broad access to preventive services, including
contraceptive services, will reduce disparities.74
As to the scope of the religious-employer exemption, the Departments stated that the exemption as adopted did not undermine the benefits of the mandated coverage because the narrow definition of religious employer helped to ensure that the employees affected would already share the employer’s beliefs.75 Additionally, in
their view, a broader exemption would result in more employees having to pay out of their own pockets for contraceptives and fewer employees using contraceptive services, which would undermine the claimed benefits of the preventive services.76
The Departments also expressed concern that expanding the scope of the religious-employer exemption would subject employees to the religious views of their employers, limit access to contraceptives, and inhibit the use of such services.77
The Departments concluded their discussion of the reasons supporting their final-final rules by briefly addressing conscience and religious freedom. The Departments believed that their rules did not undermine conscience or conscience protections because the rules neither prevented employers or others from expressing their opposition to contraceptive use, nor compelled use of contraceptives, nor required health care providers to prescribe contraceptives.78 Additionally, in their view, the
rules did not undermine conscience protections or religious exemptions recognized in other federal laws; rather, they asserted, such protections would “be respected” and “strongly enforced.”79 The Departments briefly considered the First Amendment
and RFRA, opining that their approach in the rules was consistent with both.80
73 Id. at 8727–28.
74 Id. at 8728.
75 Id.
76 Id.
77 Id.
78 Id. at 8729.
79 Id.
6. The February and August 2012 Guidance
HHS issued a guidance document regarding the one-year enforcement safe harbor for non-exempted, non-grandfathered group health plans established and maintained by nonprofit organizations with religious objections to contraceptive coverage. The guidance was first issued on February 10, 2012, and then with minor clarifying amendments on August 15, 2012.81 The safe harbor was available only to a
defined set of organizations: nonprofit organizations whose plans had consistently not covered all or the same subset of contraceptive services for religious reasons at any point from the February 10, 2012 issuance of the guidance onward.82 The
guidance document specified the criteria that employers, plans, and issuers had to meet to qualify for the safe harbor and, thereby, avoid for one year an enforcement action for failing to cover some or all of the mandated services.83 To qualify for the
safe harbor, the organization was required to execute a certification document, and the plan was required to provide participants a specified notice stating that some, or all, contraceptive coverage would not be provided under the plan for the first plan year beginning on or after August 1, 2012.84
7. The March 2012 Advance Notice of Proposed Rulemaking (ANPRM) In March 2012, the Departments issued an advance notice of proposed rulemaking (ANPRM).85 The Departments announced an intention to amend
regulations regarding certain preventive health services and to establish alternative ways of ensuring preventive health services coverage “when health coverage is sponsored or arranged by a religious organization that objects to the coverage of contraceptive services for religious reasons” but does not qualify for the religious-employer exemption.86 The Departments provided for a ninety-day comment
period.87
The Departments indicated that the ANPRM was “the first step” toward promulgating amended final rules before the end of the temporary enforcement safe harbor so that any accommodation of religious objections by non-exempt, nonprofit religious organizations would be in place at that time.88 The ANPRM made it clear
81 See Ctr. for Consumer Info. & Ins. Oversight (CCIIO), Ctrs. for Medicare & Medicaid Servs. (CMS), Guidance on the Temporary Enforcement Safe Harbor for Certain Employers, Group Health Plans and Group Health Insurance Issuers with Respect to the Requirement to Cover Contraceptive Services Without Cost Sharing Under Section 2713 of the Public Health Service Act, Section 715(a)(1) of the Employee Retirement Income Security Act, and Section 9815(a)(1) of the Internal Revenue Code, CMS.GOV (Feb. 10, 2012), available at
http://www.nacua.org/documents/HHS_HealthInsurance_Guidance.pdf. 82 Id.
83 Id.
84 Id.
85 See Certain Preventive Services Under the Affordable Care Act, 77 Fed. Reg. 16,501 (Mar. 21, 2012) [hereinafter Advance Notice]; Student Health Insurance Coverage, 77 Fed.
Reg. 16,453, 16,456–57 (Mar. 21, 2012). 86 Advance Notice, supra note 85, at 16,501.
87 Id.
that the Departments had no intention of retreating from their mandate to cover all “[FDA]-approved contraceptive methods, sterilization procedures, and patient education and counseling for all women with reproductive capacity.”89 The
Departments used the ANPRM as a means of presenting “questions and ideas to help shape” discussions with interested persons and stakeholders and to provide “an early opportunity for any interested stakeholder to provide advice and input into the policy development related to the accommodation to be made.”90 Among the larger
questions posed were: (1) Who qualifies for the accommodation?91 and (2) Who
administers the accommodation?92 Under each of these larger questions were a host
of sub-issues that required the Departments to gather information, as well as other questions related to such matters as religious health insurance issuers or third-party administrators.93 The Departments emphasized that they wanted to hear from “all
points of view on how to provide women access to the important preventive services at issue without cost sharing while accommodating religious liberty interests.”94
In the ANPRM, the Departments stated that, “[o]n February 10, 2012, [they made a] commit[ment] to working with stakeholders to develop alternative ways of providing contraceptive coverage without cost sharing in order to accommodate non-exempt, non-profit religious organizations with religious objections to such coverage.”95 The Departments indicated that, since the February 2012
announcement, they had met with representatives of various groups and stakeholders to identify issues related to the accommodation.96 These consultations, in the
Departments’ words, “began to provide more detailed information on how health
coverage arrangements are currently structured, how religious accommodations work in States with contraceptive coverage requirements, and the landscape with respect to religious organizations that offer health benefits today.”97 They also gave the
following explanation for the extended comment period:
The 90-day comment period is designed to encourage maximum input into the development of an accommodation for religious organizations with religious objections to providing contraceptive coverage while ensuring the availability of contraceptive coverage without cost sharing for plan participants and beneficiaries. The Departments seek comments on the ideas and questions outlined in this ANPRM as well as new suggestions to achieve its goals. The Departments also intend to hold listening sessions to ensure all voices are heard. This will not be the only opportunity for comment. The subsequent notice of proposed rulemaking
89 Id.
90 Id.
91 Id. at 16,504–05.
92 Id. at 16,505–07.
93 Id. at 16,504–08.
94 Id. at 16,503.
95 Id.
96 Id.
will also include a public comment period. The Departments aim to ensure that the final accommodation is fully vetted and published in advance of the expiration of the temporary enforcement safe harbor.98
8. The February 2013 Proposed Rulemaking
In February 2013, the Departments issued proposed amendments to the rules regarding coverage of certain preventive services.99 Unlike the method of rulemaking
used earlier to determine the coverage of preventive services and contraceptive services,100 the Departments this time used the standard notice-and-comment
rulemaking process: They provided notice, requested comments from interested persons on the proposed rules, set aside sixty days for the public to participate meaningfully, and allowed time for the Departments to review and evaluate the comments before finalizing and putting the rules into effect.101
In the regulatory materials, the Departments acknowledged receiving approximately 200,000 comments from a variety of stakeholders in response to the ANPRM.102 The commenters provided feedback regarding the religious-employer
exemption, the proposed accommodation, and other questions and issues raised by the Departments.103 As to the religious-employer exemption, some commenters
expressed concern that the exemption was too narrow, and others argued that the exemption should be broadened to bring it into alignment with conscience clauses and exemptions in other federal laws and to avoid issues under the First Amendment and RFRA.104 Other commenters stated that the exemption should not be broadened,
arguing that the mandate did not infringe on rights protected by the First Amendment or RFRA.105 As to the accommodation, some commenters argued that it
failed to accommodate religious objections adequately and that, even with the accommodation, plan sponsors would end up funding the coverage.106 Others argued
that the Departments should expand the accommodation to encompass a larger set of organizations that object on moral or religious grounds, and some suggested criteria used in other federal laws.107 Some commenters advocated for a narrow
98 Id. at 16,508.
99 See Coverage of Certain Preventive Services Under the Affordable Care Act, 78 Fed. Reg. 8456 (Feb. 6, 2013) [hereinafter Proposed Rules].
100 See supra Parts II.B.1, II.B.4–5.
101 SeeProposed Rules, supra note 99, at 8457. Comments were due on or before April 8, 2013.
102 Id. at 8459.
103 Id. at 8459–60.
104 Id. at 8459.
105 Id.
accommodation, arguing that the Departments should not expand the accommodation to other types of organizations.108
The Departments proposed amending the existing rules in two respects. First, the proposed rules would amend the authorization granted to HRSA to exempt group health plans that are established or maintained by certain religious employers with respect to the requirement to cover contraceptive services.109 This first modification
would adjust the qualifying criteria for the religious-employer exemption.110
Accordingly, the Departments proposed eliminating the first three criteria from the existing rules and retaining the fourth as the definition of religious employer.111 In
the Departments’ view, this approach would avoid inquiry into the purposes and the religious beliefs of employers and employees and limit the scope of the exemption to churches, synagogues, mosques, other houses of worship, and religious orders as the Departments’ exemption contemplated when the final rules were issued in 2012.112
Second, the Departments would provide accommodations to group health plans established or maintained by eligible organizations, including student health insurance coverage arranged by eligible religious institutions of higher education.113
In proposing the accommodations, the Departments specified criteria for determining the eligibility of organizations and a process for organizations to self-certify their qualification for an accommodation.114 In order to ensure that women would receive
contraceptive coverage without cost sharing, the Departments proposed means by which participants and beneficiaries would be enrolled and provided coverage by health insurance issuers independent of the objecting organizations.115 The
Departments’ goal for the proposed rules was to safeguard coverage while protecting “eligible organizations from having to contract, arrange, pay or refer for contraceptive coverage to which they object on religious grounds.”116
9. The July 2013 Final Rulemaking
In July 2013, the Departments issued their final rules regarding coverage of certain preventive services.117 These rules went into effect on August 1, 2013, and
they applied to group health plans and health insurance issuers for plan years beginning on or after January 1, 2014.118 The amendments to the religious-employer
exemption applied to plans and issuers beginning on or after August 1, 2013.119
108 Id. at 8460.
109 Id. at 8456–457, 8460.
110 See id. at 8459–460.
111 Id. at 8461.
112 Id.
113 Id. at 8457–460.
114 Id. at 8462.
115 Id. at 8462–464.
116 Id. at 8462.
117 July 2013 Final Rules, supra note 17, at 39,870.
118 Id. at 39,871.
The Departments reported receiving over 400,000 comments in response to the proposed rules, and they indicated that they considered these comments before issuing the final rules.120 Some of the arguments advanced by commentators were
that contraceptive services do not prevent disease, that some are harmful to women, and that they should not be considered preventive health services.121 The
Departments responded that the HRSA guidelines “are based on recommendations of the independent [IOM Committee], which undertook a review of the scientific and medical evidence on women’s preventive services.”122 The Departments reiterated
some of the same reasons identified in the regulatory materials accompanying their February 2012 final rules, but this time they added that contraceptives, by reducing the number of unintended pregnancies, would reduce the number of women seeking abortions.123 The Departments also responded to a wide range of comments
regarding the religious-employer exemption and the accommodations.124
In the regulatory materials accompanying these final rules, the Departments gave RFRA and the First Amendment more substantial consideration than in prior rulemakings.125 Their consideration, however, extended only to matters involving
religious employers and certain non-exempt, nonprofit religious organizations.126
The Departments expressed their view that the accommodations do not violate RFRA and that the religious-employer exemption and accommodations violate neither the Establishment Clause nor the Free Exercise Clause of the First Amendment.127 Finally, they asserted that the FDA-approved contraceptive methods,
which include Plan B, Ella, and IUDs, are not abortifacient within the meaning of federal law and do not violate federal restrictions relating to abortion.128
In these final rules, the Administration completed its rulemaking on the mandate, finalizing the rules on two remaining issues.129 First, the Administration modified the
religious-employer definition for purposes of the exemption.130 Under the final rules,
a “religious employer” is “an organization that is organized and operates as a nonprofit entity and is referred to in section 6033(a)(3)(A)(i) or (iii) of the Internal Revenue Code of 1986, as amended.”131
Second, the Administration provided accommodations for group health plans that are established or maintained by eligible nonprofit religious organizations and for
120 Id. at 39,871.
121 Id. at 39,872.
122 Id.
123 Id.
124 Id. at 39,873–88.
125 Id. at 39,886–88.
126 Id. at 39,886–88.
127 Id. at 39,888.
128 Id.
129 Id. at 39,870, 73.
student health insurance coverage arranged by eligible organizations that are institutions of higher education.132 Under the final rules, an organization has to meet
the following criteria to be eligible for an accommodation:
(1) It has to oppose providing coverage for some or all of the mandated contraceptive services on account of religious objections;
(2) It has to be organized and operate as a nonprofit entity; (3) It has to hold itself out as a religious organization; and
(4) It has to self-certify (on a specified form) that it satisfies the first three requirements.133
The rules also impose specific requirements on insurance issuers that have received a self-certification from an eligible organization.134 They must expressly
exclude contraceptive coverage from the group plan coverage and provide separate payments for any services that coverage is required for.135 Additionally, they must
segregate premium revenue collected from an eligible organization from monies used to provide payment for contraceptive services, and they must provide notice to participants and beneficiaries of the availability of separate coverage. 136
10. The June 2013 Guidance Documents
In June 2013, contemporaneous with the issuance of the final rules, the Administration issued two additional guidance documents. The first document extended the temporary enforcement safe harbor to encompass plan years beginning on or after August 1, 2013, and before January 1, 2014.137 The second was a
self-certification form for organizations seeking an accommodation under the final rules to execute.138
C. Some Observations Regarding the Processes Used to Develop the Mandate
As the preceding review of the regulatory actions that implemented the mandate shows, the important policy decision to include contraceptive methods, sterilization procedures, and patient education and counseling within the preventive health services that must be covered without cost sharing was not made by the duly-elected
132 Id. at 39,873–82.
133 Id. at 39,892.
134 Id. at 39,893, 39,895–96.
135 Id.
136 Id. at 39,893, 39,895–97.
137 Ctr. for Consumer Info. & Ins. Oversight (CCIIO), Ctrs. for Medicare & Medicaid Servs. (CMS), Guidance on the Temporary Enforcement Safe Harbor for Certain Employers, Group Health Plans and Group Health Insurance Issuers with Respect to the Requirement to Cover Contraceptive Services Without Cost Sharing Under Section 2713 of the Public Health Service Act, Section 715(a)(1) of the Employee Retirement Income Security Act, and Section 9815(a)(1) of the Internal Revenue Code, CMS.GOV (June 28, 2013), https://www.cms.gov/ CCIIO/Resources/Regulations-and-Guidance/Downloads/preventive-services-guidance-6-28-2013.pdf.
138 Ctr. for Consumer Info. & Ins. Oversight, Ctrs. for Medicare & Medicaid Servs., Self
representatives of the American people serving in the U.S. Congress. In the ACA, Congress had not defined what would be included within the coverage package of preventive health services for women. Instead, it gave that decision-making responsibility to the executive branch, and consequently the decision was made by individuals within the Administration.
The Departments chose to use truncated administrative rulemaking procedures to promulgate the mandate. By using the interim final rulemaking process, the Administration hindered meaningful public participation, hampered dialogue between policymakers and interested individuals and organizations, and prevented full vetting of the rules before they went into effect. In other words, the regulatory procedures chosen by the Administration thwarted what is supposed to be a transparent, deliberative rulemaking process in which the public has the opportunity to participate meaningfully. Consequently, the public’s interest in meaningful participation in administrative rulemaking and its interest in transparent, deliberative policy decision-making were not well served by the processes employed by the Administration to develop and impose the mandate.
In the February/March 2012 timeframe, the Administration appeared to shift its approach to rulemaking regarding the mandate.139 In the March 2012 ANPRM, the
Departments stated that they committed on February 10, 2012 (when they issued the
“final-final rules” approving the amended interim final rules, the mandate, and the narrow religious-employer exemption) to working with stakeholders to ensure the provision of contraceptive coverage without cost sharing while accommodating certain nonprofit religious organizations that were opposed to providing the mandated coverage on religious grounds. That shift is also signaled by the Departments’ transition from using interim final rulemaking to the regular notice-and-comment rulemaking process and their explanation of why they were issuing an ANPRM and providing for an extended comment period and listening sessions before issuing a subsequent proposed rulemaking and providing an additional opportunity to comment. In other words, from the February/March 2012 timeframe forward, the Departments manifested a willingness to permit meaningful public participation in rulemaking and the full vetting of the rules. However, at that point, the Department had already developed and promulgated the mandate. The only remaining issues were how narrow the religious-employer exemption would be, what sort of accommodations would be extended to certain non-exempt, nonprofit religious organizations, and how the accommodations would be administered.
A review of the Departments’ rulemaking activities shows that, once the Administration had succeeded in establishing the mandate and thereby accomplishing its key social and political objectives, it slowed the rulemaking process down and began to employ standard procedures to allow public participation in decisions regarding the scope of the religious-employer exemption and the accommodation for nonprofit, religious organizations. In other words, when the Administration turned its attention to accommodating religious beliefs and conscience objections, it decided to take its time and give the public (including those opposed to a religious-employer exemption and any accommodation of nonprofit
139 The year 2012 was a presidential election year, and the contraceptive coverage mandate had become a contentious issue. See Devin Dwyer, Poll: Americans Divided over
